E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
V0251 is a new antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis. |
V0251 es un nuevo antivertiginoso que está en desarrollo para el tratamiento de las crisis de vértigo sintomáticas |
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E.1.1.1 | Medical condition in easily understood language |
Symptomatic vertiginous crisis (Acute vertigo) |
Crisis de vértigo sintomáticas ( vértigo agudo) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047340 |
E.1.2 | Term | Vertigo |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to determine the efficacy of one single intravenous injection of 4g of V0251 on vertigo symptoms relief in patient presenting with an attack of acute vertigo from vestibular origin. |
El objetivo principal del estudio es determinar la eficacia de una dosis de 4 g de V0251 administrado por vía intravenosa en el alivio de los síntomas del vértigo en pacientes que presentan una crisis de vértigo agudo de origen vestibular |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to determine the tolerance of 4g of V0251 administered by intravenous route in a single injection. |
El objetivo secundario es determinar la tolerabilidad de 4 g de V0251 administrado por vía intravenosa |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18 to 70 years, included - Acute vertigo attack due to vestibular disorder that began within 48 hours before the inclusion - Vertigo sensation lasting more than 20 min - At least one vertigo symptom of strong intensity (?3 on the VAS ranging 0-4) on the intensity vertigo scale (see section 17.4 for details) at the moment of the inclusion - For woman of child bearing potential: negative urine or serum pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment - Able to understand the protocol and having signed the written Informed Consent Form. In case of intense vertigo, the informed consent may be signed by a third party (a trustworthy person except an investigator?s team representative or a sponsor representative) after oral consent of the patient, the Informed Consent Form then being signed by the patient before the end of the study. - Likely to be compliant during the study, in the judgement of the investigator - Affiliated to the social security system, or is a beneficiary, if applicable in national regulation |
Edad comprendida entre 18 y 70 años, ambos inclusive - Crisis de vértigo agudo debido a un trastorno vestibular que comenzó en las 48 horas anteriores a la inclusión - Sensación de vértigo que dura más de 20 minutos - Al menos un síntoma de vértigo de intensidad fuerte (?3 en la escala analógica visual de 0-4) en la escala de intensidad del vértigo (ver sección ?Criterios de evaluación?) en el momento de la inclusión - Para mujeres en edad fértil: prueba de embarazo en orina o suero negativa en la inclusión y que utilicen un anticonceptivo eficaz (esterilización quirúrgica o anticonceptivos hormonales o dispositivo intrauterino) durante al menos 2 meses antes del estudio y un mes después de finalizar el estudio, para prevenir el embarazo mientras esté expuesta al tratamiento del estudio - Capaz de entender el protocolo y haber firmado el documento de consentimiento informado por escrito. En caso de vértigo intenso, una tercera persona (una persona de su confianza que no sea un representante del equipo del investigadorInvestigador o un representante del promotorPromotor) podrá firmar el documento de consentimiento después de que el paciente haya otorgado su consentimiento oral, y posteriormente el paciente deberá firmar el documento de consentimiento antes de finalizar el estudio - Es probable que cumpla con las instrucciones durante el estudio, en la opinión del investigadorInvestigador - Afiliado o beneficiario del sistema de seguridad social, si procede, conforme a la normativa nacional |
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E.4 | Principal exclusion criteria |
Relating to pathologies: - Signs of brain, brainstem and/or cerebellar dysfunction (e.g. perioral hypoesthesia, facial paresis/palsy, dysphagia, dysarthria, limb paresis and/or hypoesthesia, coordination deficit, confusion/loss of consciousness) - Concomitant central neurological disorder that may involve vertigo or dizziness (e.g. multiple sclerosis, epilepsy, Parkinson?s disease, Arnold-Chiari?s disease, Wallenberg?s disease) - Psychogenic vertigo (e.g. vertigo associated with an evident psychiatric disease, postural phobic vertigo, vertigo induced by a conflict or a stress situation, simulation) - Patient with history of hypersensitivity to acetylleucine or excipients - Narrow angle glaucoma - Moderate to severe prostatic hypertrophy or bladder neck obstruction - Any medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize his / her health. Relating to treatments: - Use of ototoxic drugs causing vertigo or dizziness (gentamicin, streptomycin, quinine, mefloquine, methotrexate) within the last month - Use of acetylleucine within the last 3 months - Use of the following medications from the onset of symptoms, except if the dosage had been stable for at least 3 months: - Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclozine, hydroxyzine, promethazine - Calcium antagonists: cinnarizine, flunarizine - Central antidopaminergics : phenothiazines, thioxanthenes, butyrophenones, benzamides, diazepines, oxazepines, aripiprazole, pimozide, risperidone - Peripheral antidopaminergics: metoclopramide, alizapride - Histaminergics: betahistine - Anticholinergics: scopolamine (hyoscine), homatropine - GABA agonists: gabapentin, pregabalin - Ondansetron - Piribedil, piracetam, trimetazidine, ginkgo biloba - Acetazolamide - Oral steroids - Use of antiepileptic drugs (except GABA agonists if the dosage had been stable for at least 3 months) Relating to the population: - Is a family member or work associate (secretary, nurse, technician,?) of the Investigator - Is pregnant or in post-partum period or a nursing mother - Has received treatment with known persistent effects or undergone investigation liable to interfere with the present clinical trial - Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing its constraints - Has forfeited his / her freedom by administrative or legal award or is under guardianship |
Criterios relacionados con patologías - Signos de disfunción cerebral, del tronco encefálico y/o cerebelosa (p. ej.: hipoestesia perioral, paresia/parálisis facial, disfagia, disartria, paresia y/o hipoestesia de las extremidades, falta de coordinación, confusión/pérdida de conocimiento) - Trastorno neurológico central concomitante que puede incluir vértigo o mareos (p. ej.: esclerosis múltiple, epilepsia, enfermedad de Parkinson, enfermedad de Arnold-Chiari, enfermedad de Wallenberg, etc.) - Vértigo psicogénico (p. ej.: vértigo asociado a una enfermedad psiquiátrica manifiesta, vértigo fóbico postural, vértigo inducido por un conflicto o una situación de estrés, simulación, etc.) - Paciente con historia de hipersensibilidad a la acetil-leucina o a los excipientes - Glaucoma de ángulo cerrado - Hipertrofia prostática de moderada a severa u obstrucción del cuello de la vejiga - Cualquier antecedente médico de enfermedad médica o psiquiátrica importante o cirugía que, en opinión del investigadorInvestigador, pudiera poner en peligro la salud del paciente. ? Criterios relacionados con tratamientos - Uso de medicamentos ototóxicos que producen vértigo o mareos (gentamicina, estreptomicina, quinina, mefloquina, metotrexato) en el último mes - Uso de acetil-leucina en los últimos 3 meses - Uso de los siguientes medicamentos desde el inicio de los de síntomas, salvo que la dosis haya sido la misma durante al menos 3 meses: Antihistamínicos: difenhidramina, ciclizina, dimenhidrinato, meclozina, hidroxizina, prometazina Antagonistas del calcio: cinarizina, flunarizina Antidopaminérgicos centrales: fenotiazinas, tioxantenos, butirofenonas, benzamidas, diazepinas, oxazepinas, aripiprazol, pimozida, risperidona Antidopaminérgicos periféricos: metoclopramida, alizaprida Histaminérgicos: betahistina Anticolinérgicos: escopolamina (hioscina), homatropina Agonistas GABA: gabapentina, pregabalina Ondansetrón Piribedil, piracetam, trimetazidina, ginkgo biloba Acetazolamida Corticoesteroides orales - Uso de antiepilépticos (salvo agonistas GABA si la dosis ha sido la misma durante al menos 3 meses) ? Criterios relacionados con la población - Es familiar o tiene una relación laboral (secretaria, enfermera, técnico, etc.) con el investigadorInvestigador - Está embarazada o en periodo posparto o está en periodo de lactancia - Ha recibido tratamiento con efectos persistentes remanentes conocidos o ha participado en una investigación que probablemente interfiera en este ensayo clínico - Mentalmente incapaz de entender la naturaleza, objetivos y posibles consecuencias del ensayo; o no acepta las restricciones del ensayo - Ha perdido su derecho a la libertad por orden judicial o administrativa o está legalmente incapacitado |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean Vertigo Score (VSM) |
Puntuación de vértigo media (PVM) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-VSM - Mean Concomitant Symptom Score (CSSM) |
PVM Puntuación de síntomas concomitantes media (PSCM) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 and 4 hours |
2 a 4 horas |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
La última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |